Francesco Cicirello PharmD MSc BioNTech US

Francesco Cicirello currently serves as Senior Director, Global Quality Compliance – BioNTainer at BioNTech, where he leads global quality and compliance strategy supporting modular, aseptic manufacturing platforms for advanced biologics. His responsibilities span contamination control strategy (CCS), validation, aseptic process governance, inspection readiness, and the implementation of risk‑based quality systems across multi‑site and international manufacturing networks. Prior to joining BioNTech, Francesco held senior quality leadership roles in both the United States and Europe, including Senior Director of Quality Assurance at Evelo Biosciences in Cambridge, Massachusetts, and Site Quality Head at Adaptimmune in the United Kingdom, supporting development and manufacture of advanced therapeutic products from clinical through commercial stages. Earlier in his career, Francesco served as an Expert Inspector with the Therapeutic Goods Administration (TGA) in Australia, where he was directly involved in GMP inspections and regulatory oversight. He has played a role in regulatory harmonization through elected positions within the Pharmaceutical Inspection Co‑operation Scheme (PIC/S), including Chair of the Working Group responsible for revising PIC/S Annex 2 and PIC/S representative to the EMA Inspectors Working Group. Francesco is an author of PIC/S Annex 2A and 2B and a frequent industry speaker.